The plenary speaker, Mr. Jim Skine (Executive Director, Quality, Amgen), presented on “A Biotech Production Facility Contamination Case Study—Minute Mouse Virus.” The case study discussed the difficulty in inactivating the minute mouse virus, the containment and communication procedures employed, and provided an overview of investigations, corrective actions, and facility decontamination performed in the case of minute mouse virus contamination at Amgen. The breakout Session F of the workshop was held to further discuss the issues surrounding facility and equipment decontamination strategies as presented by Mr. Jim Skrine. The goal of the breakout session was to present strategies of how to approach a cell culture viral decontamination of a facility, the considerations and decision framework in developing such strategies, and case studies that presented the challenges and lessons learned from the execution of facility cleaning and fumigation processes.
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